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| Sponsored by: |
Maasland Hospital |
|---|---|
| Information provided by: | Maasland Hospital |
| ClinicalTrials.gov Identifier: | NCT00181311 |
Purpose
The purpose of this study is to evaluate the short and long term complications after an abdominal or vaginal hysterectomy and to detect the prevalence of occult/subclinical haematomas and vaginal cuff abscesses and the postoperative course of these.
The investigators will also evaluate the physical and mental well being after a hysterectomy with a questionnaire and correlate these results with the occurrence of complications.
| Condition | Intervention |
|---|---|
|
Hysterectomy |
Procedure: hysterectomy |
| Study Type: | Observational |
| Study Design: | Cross-Sectional, Defined Population, Prospective Study |
| Official Title: | Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy |
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | October 2006 |
Hysterectomy is the most common major gynaecological operation performed worldwide.
The overall average rate of hysterectomy in the United States is 5.6 per 1000 women. There are three different procedures to perform a hysterectomy. The surgery can be approached abdominally, vaginally or as a laparoscopically assisted hysterectomy.
This study will contribute to the improvement of knowledge in short and long term complications and especially the prevalence of occult and subclinical haematomas and vaginal abscesses after abdominal or vaginal hysterectomy. The occurrence of short and long term complications will have an influence on the general well being of the patient. We will also evaluate the physical and mental well being of the patient after a hysterectomy.
After statistical analysis of the study outcome parameters, some conclusions can be drawn for the treatment policy after an abdominal or vaginal hysterectomy to reduce the complication rate and improve the general well being of our patients.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Erik Jan Sollie, MD | +31(0)464597787 | e.sollie@orbisconcern.nl |
| Netherlands, Limburg | |
| Maasland Hospital | Recruiting |
| Sittard, Limburg, Netherlands, 6130 MB | |
| Contact: Erik Jan Sollie, MD +31(0)464597787 | |
| Principal Investigator: Martine Wassen | |
| Study Chair: | Erik Jan Sollie, MD | Maasland Hospital |
More Information
| Study ID Numbers: | 05-P-26 |
| Study First Received: | September 10, 2005 |
| Last Updated: | October 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00181311 |
| Health Authority: | Netherlands: Independent Ethics Committee |
|
vaginal hysterectomy abdominal hysterectomy complications physical well being mental well being |
